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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US 12/14 ARTICUL 40MM M SPEC+5 ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS

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DEPUY ORTHOPAEDICS INC US 12/14 ARTICUL 40MM M SPEC+5 ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS Back to Search Results
Catalog Number 136506000
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Pain (1994); Discomfort (2330); Depression (2361)
Event Date 12/02/2011
Event Type  Injury  
Manufacturer Narrative
No device associated with this report was received for examination. A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot code(s) was not provided. Depuy considers the investigation closed at this time. Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Manufacturer Narrative
(b)(4).
 
Manufacturer Narrative
This complaint is the subject of litigation or a legal claim and currently complete product detail is not available at this time. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. This complaint is still under investigation. Depuy will notify the fda of the results of this investigation once it has been completed.
 
Event Description
Oct 6, 2017: litigation record received. Litigation alleges pain, discomfort, soreness, friction and wear causing toxic metal ions and particles.
 
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Brand Name12/14 ARTICUL 40MM M SPEC+5
Type of DeviceARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
LEEDS MFG & MATERIAL WAREHOUSE
st anthonys road
leeds IN
UK
Manufacturer Contact
kara ditty-bovard
700 orthopaedic drive
warsaw, IN 46581-0988
6107428552
MDR Report Key6998838
MDR Text Key104471872
Report Number1818910-2017-28017
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Consumer
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 10/06/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/03/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date01/30/2014
Device Catalogue Number136506000
Device Lot Number2820689
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received12/07/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/20/2009
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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